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At least 19 recordsLinked to original sources
PubMed1992

Dose-response studies with co-dergocrine mesylate under hypoxia utilizing EEG mapping and psychometry.

In a double-blind, placebo-controlled trial, human brain function and mental performance were studied under two different degrees of hypoxia after administration of two different doses (6 mg and 9 mg) of co-dergocrine mesylate (CDM) utilizing blood gas analysis, EEG mapping and psychometry. Hypoxic hypoxidosis (i.e. impairment of cerebral metabolism due to hypoxia) was experimentally induced by a fixed gas combination of 9.8% oxygen (O2) and 90.2% nitrogen (N2) (found in 6000 m altitude), and of 8.6% O2, 91.4% N2 (found in 7000 m altitude), which was inhaled for 23 min under normobaric conditions by 18 healthy volunteers. They received randomized after an adaptation session placebo, 6 mg and 9 mg co-dergocrine mesylate (CDM). Evaluation of blood gases, brain mapping and psychometry was carried out at 0, 2, 4, 6, 8 h after oral drug administration. Blood gas analysis demonstrated a drop in PO2 to 42 and 32 mm Hg 23 min after inhalation of the 9.8% and 8.6% gas mixture, respectively, PCO2 decreased to 32 and 31 mm Hg, pH increased to 7.46 and 7.47 and base excess increased to 0.50 and 0.90 nmol/l, respectively. EEG mapping demonstrated an increase in delta and decrease of alpha power and a slowing of the centroid over almost the whole brain. 6 mg and slightly less so 9 mg CDM attenuated this deterioration of vigilance (i.e. dynamic state of the neuronal network determining adaptive behavior). At the behavioral level, moderate hypoxia induced a deterioration of noopsychic performance, which was mitigated by 6 mg, but not by 9 mg CDM. A deepening of the hypoxia resulted in a loss of these brain protective effects of both doses. Decrement of the thymopsyche increased after both doses in the moderate hypoxic condition, while under marked hypoxia 6 mg CDM attenuated and 9 mg aggravated this deterioration. Time-wise, brain protective effects reached the level of statistical difference between the 2nd and the 6th hour. Somatic complaints like feeling dazed, giddiness and headache were mitigated dose dependently by CDM in the moderate, but not in the marked hypoxic hypoxidosis.

Adult↗
PubMed1990

Brain protection of nicergoline against hypoxia: EEG brain mapping and psychometry.

In a double-blind, placebo-controlled trial human brain function and mental performance as well as the antihypoxidotic properties of nicergoline were studied utilizing blood gas analysis, EEG brain mapping and psychometry. Hypoxic hypoxidosis was experimentally induced by a fixed gas combination of 9.8% oxygen (O2) and 90.2% nitrogen (N2) equivalent to 6,000 m altitude, which was inhaled for 23 min under normobaric conditions by 16 healthy volunteers. They received randomized after an adaptation session placebo, 10 mg, 30 mg and 60 mg nicergoline (NIC). Evaluation of blood gases, brain mapping and psychometry was carried out at 0, 2, 4, 6, 8 hrs oral drug administration. Blood gas analysis demonstrated a drop in PO2 from 95 to 35 and 34 mm Hg in the 14 and 23 min of inhalation, respectively. PCO2 decreased too (38 to 34 and 34 mm Hg), while pH increased (7.39 to 7.44 and 7.44). Base excess increased (-0.6 to 0.6 and 0.4) while standard bicarbonate decreased (24.4 to 24.1 and 23.8 mmol/l). Thus, blood gases remained stable between the 14 and 23 min of hypoxia during which time the neurophysiological and behavioral evaluations were carried out. EEG brain mapping exhibited an increase in delta/theta activity mostly over the parietal, temporal and central regions (left more than right), while alpha activity decreased (mostly over the parietal, central, frontal, fronto-temporal and temporo-occipital regions). 30 and 60 mg NIC attenuated this deterioration of vigilance. At the behavioral level, hypoxic hypoxidosis induced a deterioration of the noo- and thymospsyche which was mitigated by NIC. Based on 13 psychometric variables, the hypoxia-induced performance decrement was on the overall (2nd-8th hr) 43% after placebo as compared with pretreatment normoxic values, while only 29, 24 and 31% after 10, 30 and 60 mg nicergoline, respectively. The difference between placebo and the optimal dosage of nicergoline 30 mg reached the level of statistical significance (p less than 0.01, multiple Wilcoxon).

Adult↗
PubMedDate not supplied

Effect-kinetics on brain protection of two codergocrine-mesylate preparations (Aramexe retard and Hydergine) by EEG mapping and psychometry under hypoxia.

In a double-blind, placebo-controlled study the effect-kinetics on brain protection of a new retard formulation of codergocrine-mesylate (CDM) (Aramexe retard, 5 mg) were investigated and compared with a standard CDM drug (5 mg Hydergine) utilizing blood gas analysis, EEG mapping and psychometry. A transient, reversible hypoxic hypoxidosis (i.e. impairment of cerebral metabolism due to hypoxia) was experimentally induced by a fixed gas combination of 9.8% oxygen (O(2)) and 90.2% nitrogen (N(2)) (found at an altitude of 6000 m), which was inhaled for 23 min under normobaric conditions by 18 healthy volunteers. After an adaptation session they received randomized 5 mg Aramexe retard, 5 mg Hydergine and placebo. Evaluation of blood gases, EEG mapping and psychometry was carried out at 0,2, 4,6, and 8 h after oral drug administration - each time under normoxic and hypoxic conditions. Blood gas analysis demonstrated a drop in SaO(2) from 99% under normoxia to 70% under hypoxia, in Po(2) from 100 to 33 mmHg, and in Pco(2) from 36 to 31 mmHg, while pH increased from 7.43 to 7.48. Base excess and standard bicarbonate remained stable. Under hypoxia EEG mapping exhibited an increase in delta/theta, a decrease of alpha and increase of beta activity, as well as a slowing of the centroid of the total power spectrum, which reflects deterioration of vigilance. Both CDM preparations significantly attenuated this vigilance decrement, with 5 mg Hydergine showing its encephalotropic peak effect in the second hour, 5 mg Aramexe retard in the sixth and eighth hours. At the behavioral level, hypoxic hypoxidosis induced a deterioration of the noo- and thymopsyche (by 53% under placebo), which was significantly mitigated by both 5 mg Aramexe retard (19%) and Hydergine (32%).

Clinical Trial↗
PubMed1988

Computerized psychometry screening in long-term survivors of childhood acute lymphoblastic leukemia.

This study assessed the diagnostic utility of a computerized psychometry battery of tests: the Bexley-Maudsley Automated Psychological Screening Test and Category Sorting Test in the screening for deficits in cognitive function in a population of children who had been treated for acute lymphoblastic leukemia. Central nervous system therapy with radiotherapy and intrathecal chemotherapy has been incriminated as a cause of psychological morbidity in survivors. Twenty-nine children who were surviving in their first hematological remission, following cessation of their treatment for acute lymphoblastic leukemia, were studied. No child had evidence of central nervous system leukemic involvement, and they were all attending normal schools. Their performances were compared with 29 control children matched by age, sex, and social class. The children treated for leukemia showed a reduced ability to sustain attention (p less than 0.025), a reduction in verbal recognition short term memory (p less than 0.02), and difficulties in abstract problem solving (p less than 0.01). These results confirm the presence of neurophysical morbidity in children treated for acute lymphoblastic leukemia. It is suggested that this computerized psychometry test battery is a useful method for examining children at risk of neurological impairment and identifies specific deficits that require further evaluation and remedial help.

Adolescent↗
PubMed2002

Pharmacodynamic studies on the central mode of action of S-adenosyl-L-methionine (SAMe) infusions in elderly subjects, utilizing EEG mapping and psychometry.

In a double-blind, placebo-controlled cross-over study, the acute and subacute effects of S-adenosyl-L-methionine (SAMe), or ademetionine, on brain function and behavior of 10 elderly normal healthy volunteers (5 males and 5 females, aged 56-71 years, mean: 59.3 years) were investigated by means of EEG mapping and psychometry. In random order they received infusions of 800 mg SAMe and placebo, administered over 30 minutes for 7 days, with a wash-out period of 3 weeks in between. EEG recordings and psychometric tests were carried out 0, 1, 3 and 6 hours after drug administration on days 1 and 7. Multivariate analysis based on MANOVA/Hotelling T(2) tests demonstrated significant central effects of SAMe as compared with placebo after acute, subacute and superimposed drug administration. Acute SAMe-induced changes were characterized by a decrease in total power, an increase in absolute delta and a decrease in absolute alpha power, further by an increase in relative delta and a decrease in relative alpha power, a slowing of the delta/theta centroid as well as a slowing of the centroid of the total power spectrum. These changes are typical of classical antidepressants of the thymoleptic type such as imipramine and amitriptyline. After one week of daily infusions there was a marked increase in total power, reminiscent of nootropic drug effects. One additional superimposed dosage mitigated these effects in the direction of an antidepressant profile, with the inter-drug differences waning in the 6(th) hour. Our pharmaco-EEG findings suggest both inhibitory and excitatory drug effects underlying the antidepressant properties of SAMe well-documented in clinical trials. Psychometric tests concerning noopsychic and thymopsychic measures as well as critical flicker frequency generally demonstrated a lack of differences between SAMe and placebo, which again reflects a good tolerability of the drug in elderly subjects.

Aged↗
PubMed1986

Event-related potentials in patients with Huntington's disease and relatives at risk in relation to detailed psychometry.

Event-related potentials (ERPs) were studied in patients with Huntington's disease (HD) and their offspring at risk in a simple auditory oddball paradigm requiring the counting of the rarer of two stimulus categories. Group statistical analysis revealed prolongation of latencies of components P2, N2 and especially P3 in HD patients and to a lesser extent in at-risks. In a large population of normals the age-latency relationship for component P3 showed a non-linear shape with increasing slope and scatter in the older age groups. A bipartate linear regression analysis splitting the normal population at age 50 was used for detection of abnormalities of P3 latency in individual cases. Abnormal P3 latencies were present in the majority of HD patients and also in 25% of clinically normal at-risks. Correlation analysis of ERP components with detailed psychometry revealed a particularly high association of P3 latencies with measurements requiring speeded information processing in non-verbal tasks. P3 amplitude did not covary with performance scores but unlike P3 latency showed association with depression and psychosis scores. From the results it appears that analysis of ERPs is a useful electrophysiological tool for an objective assessment of cognition both in clinically definite and subclinical stages.

Adolescent↗
PubMed2005

Double-blind, placebo-controlled pharmacodynamic studies with a nutraceutical and a pharmaceutical dose of ademetionine (SAMe) in elderly subjects, utilizing EEG mapping and psychometry.

In a double-blind, placebo-controlled crossover study, the effects of S-adenosyl-l-methionine (SAMe) on brain function measures of 12 normal elderly volunteers (6 m/6 f, aged 57-73 years, mean: 61 years) were investigated by means of EEG mapping and psychometry. In random order, the subjects were orally administered a pharmaceutical dose of 1600 mg SAMe, a nutraceutical dose of 400 mg SAMe and placebo, each over a period of 15 days, with wash-out periods of 2 weeks in between. EEG recordings, psychometric tests and evaluations of tolerability and side effects were carried out 0, 1, 3 and 6 h after drug administration on days 1 and 15. Multivariate analysis based on MANOVA/Hotelling T2 tests of quantitative EEG data demonstrated significant central effects of SAMe as compared with placebo after acute, subacute and superimposed drug administration of both the nutraceutical and the pharmaceutical dose. EEG changes induced by SAMe were characterized by an increase in total power, a decrease in absolute and relative power in the delta/theta and slow alpha frequencies, an increase in absolute and relative power in the alpha-2 and beta frequencies as well as an acceleration of the alpha centroid and the centroid of the total power spectrum. The delta/theta and the beta centroid showed variable changes over time. The dominant alpha frequency was accelerated, the absolute and relative power in the dominant alpha frequency attenuated after SAMe as compared with placebo. These acute and subacute pharmaco-EEG findings in elderly subjects are typical of activating antidepressants. Time-efficacy calculations showed that acute oral administration of SAMe in both the nutraceutical and the pharmaceutical dose induced the pharmacodynamic peak effect in the first hour with a subsequent decline. The 3rd and 6th hours still showed a significant encephalotropic effect after the 1600 mg dose. The maximum EEG effect was noted after 2 weeks of oral administration of both 1600 mg/die and 400 mg/die. The superimposed dose induced significant encephalotropic effects in the 3rd hour after 400 mg and in the 3rd and 6th hours after 1600 mg as compared with pre-treatment. Dose-efficacy calculations showed that the pharmaceutical dose of 1600 mg had a more pronounced effect on the CNS than the nutraceutical dose of 400 mg, with both doses being superior to placebo. Psychometric tests concerning noopsychic and thymopsychic measures as well as critical flicker fusion frequency generally demonstrated a lack of differences between SAMe and placebo, which reflects a good tolerability of the drug in elderly subjects. This was corroborated by the findings on side effects, pulse and blood pressure.

Aged↗
PubMed1994

[A new method for assessment of mental performance during simultaneous, quantitative, topographical electroencephalometry and psychometry in pharmacology. Proof of the effect of a combination of biogenic amines, vitamins, minerals and trace elements].

Assessment of the Mental Performance during Simultaneous Quantitative Topographical Electroencephalometry and Psychometry in Pharmacology/Proof of influence of a biogenic amine-vitamin combination. The aim of this study was to verify the effect of a combination medicine (Vita-Gerin-Geistlich) on the human EEG pattern during psychometric (cognitive) tests given to 43 patients with poor concentration and thinking problems. A randomised, parallel, placebo-controlled double-blind study was performed. Applying 17-channel quantitative electroencephalometry and psychometric tests simultaneously this study revealed a test-dependent increase in absolute spectral EEG power in the delta and theta frequency bands, mainly observed in the frontotemporal cortex. After 8 weeks the increase in EEG power differed significantly with respect to taking placebo and verum (1 capsule/day). Verum caused a stronger rise in spectral delta and theta power, the psychometric test performance also improved. Both effects could be verified statistically. The novel EEG-controlled psychometric test set (enabling artefact-free EEG recording during psychometric tests) which was developed and used in this study represents a valid tool for future pharmacological research.

Adult↗
PubMed1996

Comparative pharmacodynamic studies with the novel serotonin uptake-enhancing tianeptine and -inhibiting fluvoxamine utilizing EEG mapping and psychometry.

In a double-blind, placebo-controlled study, the encephalotropic and psychotropic effects of tianeptine (TIA)--a new tricyclic antidepressant, enhancing serotonin reuptake--were investigated as compared with the serotonin reuptake inhibiting antidepressant, fluvoxamine (FLU), utilizing EEG mapping, psychometric and psychophysiological measures. 16 healthy volunteers (8 males, 8 females) aged 21-35 (man 27) years received randomized and at weekly intervals single oral doses of placebo, 12.5 and 25 mg TIA and 50 mg FLU. EEG recordings, psychometric and psychophysiological tests and evaluation of pulse, blood pressure and side effects were carried out at 0, 2, 4, 6 and 8 hours; blood sampling, in addition, at hour 1. TIA plasma levels rose fast to peaks at 1-2 hours and declined rapidly as well, while the MC5 metabolite peaked in the 4th hour and declined more slowly. EEG mapping demonstrated that both TIA and FLU induced significant changes in brain function between the 1st and 8th hour, which, however, differed in their time course. 12.5 mg TIA exhibited, as compared with placebo, slight activating properties in the EEG (decrease of delta and theta, increase of alpha and beta, acceleration of the centroid), parallelled by thymopsychic improvement (mood elevation). 25 mg TIA showed EEG activation up to the 4th hour, later EEG sedation, accompanied by an initial thymopsychic improvement and differential changes thereafter (improved mood, decreased vigility), with the noopsyche improving at all times (attention, Pauli test). 50 mg FLU induced initially sedation and thereafter activation, accompanied by thymopsychic deterioration and subsequent improvement, the latter also being observed in the noopsyche (attention, memory). In pupillary and skin conductance measures, generally a slight activation occurred after placebo, which was attenuated by 25 mg TIA. Correlation maps between plasma levels and EEG changes demonstrated: the higher the TIA plasma levels, the more absolute and relative beta power, the less alpha power and the faster the centroid of the total power spectrum, reflecting CNS-activation. Topographically, the correlations were mostly seen over both fronto-temporal regions. In the latter, dominant frequency signalled desactivation in the right and activation in the left hemiphere after both antidepressants which, thereby induced changes in brain function opposite to those observed in depression. Both drugs were well tolerated.

Adult↗
PubMed1984

Classification and determination of pharmacodynamics of a new antihypoxidotic drug, vinconate, by pharmaco-EEG and psychometry.

In a double-blind, placebo-controlled study the encephalotropic and psychotropic properties of both orally and intravenously administered doses of vinconate (OC 340)--a new vincamine analogue--were studied in 10 elderly subjects in their sixties by means of quantitative EEG and psychometric analyses. They received at weekly intervals randomized single oral doses of placebo, 40 mg, 80 mg and 160 mg vinconate orally as well as placebo and 30 mg vinconate intravenously. EEG recordings and the monitoring of blood pressure, heart rate and side effects were carried out at the hours 0, 1, 2, 4 and 6. Psychometric tests were performed at the hours 0, 2, 4 and 6. Computer-assisted spectral analysis of the EEG showed a significant CNS effect of vinconate as compared with placebo characterized by a decrease of delta activity, increase of alpha and specifically of alpha-adjacent slow beta activity as well as an acceleration of the centroid of the total activity. Such changes were described previously by us after several other antihypoxidotics and are indicative of improvement in vigilance in the sense of Head (Br. J. Psychol., 14, 125-147). The encephalotropic effect was most pronounced after 160 mg vinconate p.o. followed by 80 mg and 40 mg vinconate orally, which timewise could be observed best in the 6th hour after drug administration. Changes after the i.v. injection of vinconate peaked as early as the 2nd hour post-drug. Psychometric investigations demonstrated only small psychotropic effects, which rarely reached the level of statistical significance as compared with placebo. Generally, the orally administered vinconate induced a trend towards an improvement of psychomotor activity, complex reaction and cognitive function as well as a significant improvement in attention and concentration, while the von Zerssen score increased as compared with placebo. 30 mg vinconate i.v., however, induced an improvement in mood as well as a shortening of reaction time and activation in the after-effect as compared with placebo in addition to a trend towards improvement in psychomotor activity, complex reaction and Pauli test. Evaluation of pulse rate, blood pressure and side effects showed a good tolerance of the drug. The findings are discussed.

Aged↗
PubMed2006

[From psychometry to neuropsychological disability in multiple sclerosis: a new brief French cognitive screening battery and cognitive risk factors].

INTRODUCTION: Cognitive deficit in multiple sclerosis (MS) is a frequent early feature in the disease course, which conditions patients' overall disability. The goals of this study were to validate a reproducible brief screening battery written in French and to examine cognitive risk profiles in patients with a mild physical disability. METHODS: Cognitive performances of 40 patients with EDSS <4.5 were compared with those of a control group. The study was completed with an analysis of socio-demographic, clinical and psychological variables (questionnaires). RESULTS: Three tests were discriminative with satisfactory predictive values (positive: 88 percent; negative: 96 percent) and a time duration <30 minutes: PASAT (hard condition), backward digit span, learning stage of California Verbal Learning Test. Four variables were associated with cognitive deficit: educational level <11 years, age >40 years, pathological laughing-crying, unemployment. CONCLUSIONS: Our brief battery is an easy and reproducible tool. Completed with warning signs indicating the need for neuropsychological screening, this tool provides the practitioner with a global means of assessing disease activity and potentially therapeutic efficacy.

Adult↗
PubMed1987

Comparative placebo-controlled pharmacodynamic studies with zotepine and clozapine utilizing pharmaco-EEG and psychometry.

In a double-blind, placebo-controlled study the encephalotropic and psychotropic properties of zotepine - a new tricyclic dibenzothiepine with antidopaminergic, adrenolytic and antiserotoninergic properties - were investigated utilizing quantitative EEG, psychometric and psychophysiological tests as well as clinical observations. Fifteen normal volunteers received randomized (latin square design) and at weekly intervals single oral doses of placebo, 25 mg, 50 mg and 100 mg zotepine as well as 50 mg clozapine as reference compound. Plasma samplings for blood levels, EEG recordings, and evaluation of blood pressure, pulse rate and side-effects were carried out at the hours 0, 1, 2, 4, 6 and 8, while psychometric data were recorded at the same time except the first hour. Computer-assisted spectral analysis of the EEG demonstrated after all three doses significant changes as compared with placebo characterized by an augmentation of delta and theta activity, decreased of alpha and beta activity, slowing of the centroid of the total activity and alpha activity, and decrease of the dominant frequency and its absolute and relative power. Such changes are typical for low-potency basic neuroleptics of the sedative type such as chlorpromazine. Clozapine also augmented slow activities, decreased alpha activity, the dominant frequency and the alpha centroid, but induced in contrast to zotepine a concomitant increase of fast beta activity, acceleration of the beta centroid and no slowing of the dominant frequency, while the total power was significantly attenuated. These findings confirm earlier reports about the pharmaco-EEG profile of clozapine, which has a resemblance to profiles of anticholinergic antidepressants of the amitriptyline type. Psychometric tests demonstrated after the higher doses of zotepine and clozapine a deterioration of noopsychic and thymospsychic functions which was more pronounced after the reference compound than after zotepine. The lowest dose of zotepine, 25 mg, even produced an improvement in numerical memory and complex reaction. CFF, skin conductance, pupillary diameter and pupillary response measurements decreased after both compounds. Dose-efficacy calculations showed 100 mg zotepine and clozapine to be the most CNS-effective compounds, followed by 50 mg and 25 mg zotepine, while placebo induced the least changes. Time-efficacy calculations showed neurophysiological and behavioral peak effects after zotepine at the 4th and 6th hour, as compared with the 2nd and 4th hour after clozapine. Pulse rate increased with both compounds; blood pressure decreased after clozapine but remained unchanged after zotepine.(ABSTRACT TRUNCATED AT 400 WORDS)

Adult↗
PubMed1980

[Psychometry and psychological observations in early treated children with phenylketonuria (PKU) during 12 years (author's transl)].

Among 81 PKU's uncovered until 1978/12/31 63 were 1 to more than 8 years old so at least once up to 4 times psychometrically examined. Although the IQ's at 8 years were still in the normal rang there was a slight but between 6 and 8 years statistically significant (p less than 0.01) decline in IQ. There is no correlation between this decline and the diet introduction age (26--29, average 26,4 days) nor the diet discontinuation age (4 to 8 years) and the predominantly good diet quality. But there were relations to the parental IQ. It seems remarkable that the centers of London and Warschau report declines of the same extent at approximately the same ages in spite of different diet discontinuation ages. The IQ losses in the patients derive almost totally from losses in the verbal part of the tests. Also the slight but statistically significant IQ deficits demonstrated in heterozygotes for PKU (parents) arise almost entirely from the verbal quotient. It is supposed that both observations are phenylalanine blood level independent phenomena. The demonstration of statistically highly significant augmentations of intracellular phenylalanine (and tyrosine) in heterozygotes and homozygotes for PKU may indicate an explanation. Our early treated children with PKU show the same weakness in concentration, perseverance and cognitive abilities (mathematics, orthography, picture coordination) as observed by other centers. These disabilities are largely IQ independent, influence school work adversely but can be improved by psychological promotion. Children with hyperphenylalaninemia do not show the slight decline in IQ nor the specific disabilities.

Age Factors↗
PubMed1996

"Telepsychometry": a remote psychometry consultation in clinical gerontology: preliminary study.

OBJECTIVE: Evaluation of the clinical feasibility of remote psychometric consultation with elderly patients. METHODS: Remote consultation with six women and four men (average age 87) was compared with a standard consultation. An interview and two psychometric tests were used: the Mini-Mental Status Examination (MMSE) and the Clock Face Test (CFT), which were administered by a clinical psychologist and controlled by a psychologist observer who remained in the room with the patient. The experimental setting consisted of two rooms linked by a coaxial cable. Each room was equipped with a camera, television screen, and microphone. The clinician was able to operate the mobile camera in the patient's room by remote control. The clinician was assisted by a computer, which helped to focus on standardized points. A video camera recorded the consultation for documentation purposes. RESULTS: Decreased performance was observed in the remote versus the standard consultation for both tests (MMSE: p = 0.008; CFT: p = 0.006). Physiologic hearing loss may have been responsible for a fall in the patients' attention. CONCLUSION: Remote psychometric consultation can be applied successfully to the psychological examination of elderly patients provided that communication problems are solved.

Aged↗
PubMed1986

Pharmacokinetic and dynamic studies with a new anxiolytic imidazo-pyridine alpidem utilizing pharmaco-EEG and psychometry.

In a double-blind, placebo-controlled study the pharmacokinetic and pharmacodynamic effects of a new imidazo-pyridine derivative, alpidem (SL80.0342) and the 1,4 benzodiazepine lorazepam were investigated utilizing quantitative EEG and psychometric testing. Ten normal volunteers received randomized (latin square) single oral doses of placebo, 25 mg, 50 mg and 100 mg alpidem and 2.5 mg lorazepam at weekly intervals. Blood level sampling, EEG recordings, evaluation of pulse, blood pressure and side-effects were carried out at 0, 1, 2, 4, 6 and 8 hours post drug; psychometric and psychophysiological investigations at the same time periods except for the first hour. Computer-assisted spectral-analysis of the EEG demonstrated an anxiolytic profile after both compounds, characterized by an increase of beta activity, decrease of alpha activity and acceleration of the centroid of the total activity and total beta activity. Total power was attenuated, delta activity augmented and the centroid of the combined delta and theta activities decreased. The latter changes were most pronounced after 2.5 mg lorazepam suggesting it is more sedative than alpidem. Dose/treatment efficacy calculations revealed 2.5 mg lorazepam as the most CNS-active compound, followed by 100 mg, 50 mg and 25 mg alpidem. Based on a multivariate analysis 2.5 mg lorazepam could be differentiated from placebo at all times, 100 mg alpidem in the first, second and fourth hours, 50 mg only in the second hour. Time-efficacy calculations showed a marked CNS effect after alpidem in the first hour with a peak in the second hour, a gentle decline to the fourth hour and thereafter a rapid decline up to the eighth hour. In contrast, 2.5 mg lorazepam showed a slower rise in CNS activity which peaked in the fourth hour and declined slowly thereafter. These pharmacodynamic effects paralleled the blood level course of both compounds, as well as the time-course of psychometric changes. The latter were characterized by a deterioration in psychometer function after 2.5 mg lorazepam, which was less pronounced after 100 mg alpidem, while 50 mg and 25 mg showed no significant difference from placebo. Subjective ratings of mood showed a decrement which was most pronounced after 100 mg alpidem, less so after 50 mg, with no difference from placebo after 25 mg or lorazepam. Finally, there were no significant inter-drug differences with regard to psychophysiological variables.

Adult↗
PubMed1988

Comparative bioavailability studies with a new mixed-micelles solution of diazepam utilizing radioreceptor assay, psychometry and EEG brain mapping.

In a double-blind, placebo-controlled study the pharmacokinetic and pharmacodynamic properties of a standard solution of diazepam (DZ) (ValiumR) were compared with those of a novel diazepam mixed-micelles solution (DZ MM) (Valium MMR) both after i.v. and i.m. application utilizing radioreceptor assay, quantitative pharmaco-EEG and brain mapping techniques as well as psychometric and psychophysiological methods. The local tolerance was studied as well. The subjects received randomized and, in weekly intervals, following injections: (1) 10 mg DZ i.v. + placebo i.m.; (2) 10 mg DZ MM i.v. + placebo i.m.; (3) placebo i.v. + 10 mg DZ i.m.; (4) placebo i.v. + 10 mg DZ MM i.m.; (5) placebo i.v. + placebo i.m. Blood sampling, EEG-recordings, psychometric and psychophysiological tests as well as tolerance evaluations were carried out at 0, 1/2, 1, 2, 4, 6 and 8 h. Blood level evaluation demonstrated after i.m. application a significantly shortened tmax, a higher Cmax and generally higher plasma concentrations in the first and second hour following the mixed-micelles solution than the standard formulation, which suggests better absorption of the former than the latter in the muscle. Subsequent to i.v. administration, lower blood levels were observed between 30 min and 2 h after DZ MM than DZ. Power spectral density analysis of the EEG resulted in typical anxiolytic-sedative pharmaco-EEG profiles after all 4 active substances as compared with placebo. However, there were significant inter-drug differences as far as topographic aspects (pharmaco-EEG maps) were concerned. DZ MM i.v. induced significantly more initial but also late delta augmentation, alpha attenuation and centroid slowing than DZ i.v. which suggests more sedative effects at those times. Following i.m. application, a significantly more pronounced delta/theta attenuation, beta augmentation and centroid acceleration after DZ MM than DZ suggested more anxiolytic effects of the novel than the standard formulation. Discriminant analysis of changes in 6 thymopsychic, 12 noopsychic and 17 psychophysiological variables demonstrated the best discrimination of the 4 substances based on thymopsychic effects. Considering the latter, all 4 active compounds differed significantly from placebo, with no inter-drug differences after i.v. application but a marked superiority of the novel mixed-micelles solution over the standard solution after i.m. application. Specifically, DZ MM i.m. induced more desactivation and affect-attenuation than DZ i.m.(ABSTRACT TRUNCATED AT 400 WORDS)

Adult↗